COPE - COVID-19 in Pregnancy and Early Childhood

Sponsor

Sahlgrenska University Hospital, Sweden (Other)

Overall Status

Recruiting

CT.gov ID

NCT04433364

Collaborator

(none)

1,200

Enrollment

Locations

252

Anticipated Duration (Months)

44.4

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Purpose: The emergence of a new coronavirus SARS-CoV-2 causing a novel infection in the human race resulting in a world-spanning pandemic came as a surprise and at a tremendous cost both for individual human lives as well as for the society and the health care sector. The knowledge on how this new infection affects both the mother and the unborn child as well as the outcomes for the mother and the child in the long run are unknown. What is known is based on case-reports and small case-series solely. Both the coronaviruses causing Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS) can cause a threat to pregnant women and their offspring, which leads to the question whether this could be the case also for SARS-CoV-2.

Aims: To establish a biobank of biological material from infected as well as non-infected pregnant women and their offspring. To combine this biobank with Swedish quality and health care registers, computerized patient charts and questionnaire data, enabling both short-term follow up, such as obstetric outcomes, as well as long-term outcomes both for mother and child. To study how the pandemic situation affects both the mother and her partner in their experience of pregnancy, childbirth, and early parenthood.

Design: A national Swedish multicentre study. Women are included when they have a positive test for SARS-CoV-2 or a clinical suspicion of coronavirus disease 2019 (COVID-19) (COVID-19 group). Pregnant women without COVID-19 symptoms will be included at their routine visits (Screening group). Blood samples and other biological material will be collected at different time-points. Additional predictors and outcomes are collected from the Swedish Pregnancy Register as well as obligatory Swedish health registers. The biobank and its linkage to health registers through the Swedish personal identification number will enable future research. Child development will be followed during the first year of life by questionnaires to the parents. Womens' and their partners' experience of childbirth and parenthood will be studied in form of questionnaires as well as in form of interviews.

Conclusion: This project will help obstetricians and neonatologists better recognize clinical manifestations of the virus, identify possible risk factors during pregnancy and tailor therapies alongside providing right level of surveillance and management during pregnancy, delivery, and child health care.

Condition or Disease	Intervention/Treatment	Phase
Sars-CoV2 Covid-19 Pregnancy Complications Pregnancy Preterm Pregnancy in Diabetic Neonatal Infection	Other: biological samples, questionnaires and interviews

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

COPE - COVID-19 in Pregnancy and Early Childhood - a Study Protocol for a Prospective Multicentre Cohort Study

Actual Study Start Date :

Jun 2, 2020

Anticipated Primary Completion Date :

Jun 2, 2021

Anticipated Study Completion Date :

Jun 2, 2041

Arms and Interventions

Arm	Intervention/Treatment
Screening group a general population of women giving birth, called "screening group" included at routine antenatal visits, their partners, and children	Other: biological samples, questionnaires and interviews Biological samples: to study impact of testing positive for SARS-CoV-2 during pregnancy samples taken in routine clinical care, samples from already existing research biobanks and the newly established COPE biobank will be used. Time-points: inclusion, at delivery mother and fetus. Covid-19 positive group only: 48-96 h, 2 months postpartum for mother and fetus. Questionnaires: Women and partners in both groups will fill out electronical questionnaires at different time points during pregnancy and until 12 months postpartum based on validated instruments to test for differences in Self-Efficacy, Anxiety and Depression, Health-related quality of life, Sense of Coherence, PTSD Symptoms, Postpartum Bonding, Childbirth experiences and Self-Efficacy of Breastfeeding. The child's health will be assessed regarding infection until 6 weeks of age and development until 4 years. Interviews: 24-40 women and partners in both groups. Interviews will be conducted 3 to 6 months after childbirth.
COVID-19 group group of women testing positive for SARS-CoV-2 or falling ill with COVID-19, called "COVID-19 group", their partners, and children	Other: biological samples, questionnaires and interviews Biological samples: to study impact of testing positive for SARS-CoV-2 during pregnancy samples taken in routine clinical care, samples from already existing research biobanks and the newly established COPE biobank will be used. Time-points: inclusion, at delivery mother and fetus. Covid-19 positive group only: 48-96 h, 2 months postpartum for mother and fetus. Questionnaires: Women and partners in both groups will fill out electronical questionnaires at different time points during pregnancy and until 12 months postpartum based on validated instruments to test for differences in Self-Efficacy, Anxiety and Depression, Health-related quality of life, Sense of Coherence, PTSD Symptoms, Postpartum Bonding, Childbirth experiences and Self-Efficacy of Breastfeeding. The child's health will be assessed regarding infection until 6 weeks of age and development until 4 years. Interviews: 24-40 women and partners in both groups. Interviews will be conducted 3 to 6 months after childbirth.

Arm

Intervention/Treatment

Screening group

a general population of women giving birth, called "screening group" included at routine antenatal visits, their partners, and children

Other: biological samples, questionnaires and interviews

Biological samples: to study impact of testing positive for SARS-CoV-2 during pregnancy samples taken in routine clinical care, samples from already existing research biobanks and the newly established COPE biobank will be used. Time-points: inclusion, at delivery mother and fetus. Covid-19 positive group only: 48-96 h, 2 months postpartum for mother and fetus. Questionnaires: Women and partners in both groups will fill out electronical questionnaires at different time points during pregnancy and until 12 months postpartum based on validated instruments to test for differences in Self-Efficacy, Anxiety and Depression, Health-related quality of life, Sense of Coherence, PTSD Symptoms, Postpartum Bonding, Childbirth experiences and Self-Efficacy of Breastfeeding. The child's health will be assessed regarding infection until 6 weeks of age and development until 4 years. Interviews: 24-40 women and partners in both groups. Interviews will be conducted 3 to 6 months after childbirth.

COVID-19 group

group of women testing positive for SARS-CoV-2 or falling ill with COVID-19, called "COVID-19 group", their partners, and children

Other: biological samples, questionnaires and interviews

Outcome Measures

Primary Outcome Measures

Biobank with linkage to registers [1-20 years]
establish a biobank and database with bio-samples from both women that are not tested and presumed healthy as well as possibly ill and women confirmed tested positive for SARS-CoV-2 and their infants linked to Swedish health care registers including socio-economic factors and use serological and viral analyses from the biological samples to evaluate maternal, fetal and neonatal outcomes.
Experiences of pregnancy during a pandemic [1 year]
study how women and their partners experience pregnancy, childbirth and early parenthood in the COVID-19-pandemic, both for women not tested and for women tested positive for SARS-CoV-2.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Pregnant women 18 years of age and above
Attending routine antenatal visits at a participating hospital during the study period or are strongly suspicious of or diagnosed with Covid-19 during pregnancy.
For the questionnaire part: language knowledge (Swedish, English, Arabic, Somali)
For the interview part: Swedish language knowledge

Exclusion Criteria:

• Another language but selected ones

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Falu Hospital	Falun	Dalarna	Sweden	79182
2	Halmstad lasarett	Halmstad	Halland	Sweden	30233
3	Varbergs sjukhus	Varberg	Halland	Sweden	43237
4	Helsingborgs lasarett	Helsingborg	Skåne	Sweden	25223
5	Skåne Universitetssjukhus	Lund	Skåne	Sweden
6	Eskiltuna hospital	Eskilstuna	Södermanland	Sweden	63003
7	Boras hospital	Boras	VGR	Sweden	50182
8	Sahlgrenska Univeristy Hospital	Gothenburg	VGR	Sweden	41685
9	Ryhovs sjukhus	Jönköping		Sweden
10	Kalmar Lasarett	Kalmar		Sweden
11	Karlstad lasarett	Karlstad		Sweden
12	Kristiandstad länssjukhus	Kristianstad		Sweden
13	Skaraborgs sjukhus Skövde	Skövde		Sweden
14	BB Stockholm	Stockholm		Sweden
15	Danderyd	Stockholm		Sweden
16	Karolinska University Hospital Solna	Stockholm		Sweden
17	Karolinska University Hospital- Huddinge	Stockholm		Sweden
18	Södersjukhuset	Stockholm		Sweden
19	Södertälje	Stockholm		Sweden
20	Sundsvall	Sundsvall		Sweden
21	Umeå University Hospital	Umeå		Sweden
22	Uppsala University Hospital	Uppsala		Sweden
23	Västerås	Västerås		Sweden
24	Ystad	Ystad		Sweden
25	Örebro University Hospital	Örebro		Sweden
26	Linköping University Hospital	Linköping	Östergötland	Sweden
27	Vrinnevisjukhuset	Norrköping	Östergötland	Sweden